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EXHIBIT 10.1
AMENDED AND RESTATED LICENSE AGREEMENT
BETWEEN
XXXXX-XXXXXXX XXXXX INC.
(as successor to XXXXX GROUP INC.)
AND
NOVEN PHARMACEUTICALS, INC.
SEPTEMBER 30, 1999
(Menorest Product)
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TABLE OF CONTENTS
Page
----
RECITALS............................................................................1
ARTICLE I - DEFINITIONS.............................................................1
1.1 Affiliates........................................................1
1.2 ***...............................................................1
1.3 Clinical and Product Development Program..........................2
1.4 Control...........................................................2
1.5 Costs.............................................................2
1.6 Estrogen Transdermal Drug Delivery System.........................2
1.7 European Economic Area............................................2
1.8 Excluded Countries................................................2
1.9 Final Processing..................................................2
1.10 Licensed Product..................................................2
1.11 Machine...........................................................2
1.12 Net Sales.........................................................2
1.13 Noven's Machine Patent Rights.....................................3
1.14 Noven's Patent Rights.............................................3
1.15 Noven's Processing Technology.....................................3
1.16 Noven's Technology................................................3
1.17 Packaging Materials...............................................3
1.18 Packaging Material Costs..........................................3
1.19 Standard Packaging................................................3
1.20 Sublicensee.......................................................3
1.21 Territory.........................................................3
ARTICLE II - OBLIGATIONS OF NOVEN...................................................4
2.1 Supply and Use of Information.....................................4
ARTICLE III - ONGOING DEVELOPMENT OBLIGATIONS.......................................4
3.1 Governmental Approvals............................................4
3.2 Supply of Information.............................................4
3.3 Diligence.........................................................4
3.4 Completion of Clinical and Product Development Program............4
ARTICLE IV - GRANT..................................................................5
4.1 License...........................................................5
4.2 Sublicense........................................................5
ARTICLE V - PAYMENTS................................................................5
5.1 Initial Payments..................................................5
5.2 Fee...............................................................5
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5.3 Minimum Fee.......................................................7
5.4 Payments..........................................................8
5.5 Currency..........................................................8
5.6 Records...........................................................8
5.7 One Royalty.......................................................8
5.8 Compulsory License................................................8
5.9 Samples and Placebos..............................................8
ARTICLE VI - SUPPLY.................................................................9
6.1 Agreement to Supply...............................................9
6.2 Final Processing of Licensed Product..............................9
6.3 Bulk Rolls........................................................9
6.4 Processing Technology and Equipment..............................10
6.5 Packaging........................................................11
ARTICLE VII - PATENTS..............................................................12
7.1 Noven Inventions.................................................12
7.2 Joint Inventions.................................................12
7.3 Reciprocal Rights to Exploit Data................................12
ARTICLE VIII - CONFIDENTIALITY OBLIGATIONS.........................................12
8.1 Confidentiality..................................................12
ARTICLE IX - TERM AND TERMINATION..................................................13
9.1 Term.............................................................13
9.2 Termination......................................................13
ARTICLE X - NOVEN WARRANTIES.......................................................14
10.1 Ownership........................................................14
10.2 Right to Enter Agreement.........................................14
10.3 Product Warranty.................................................14
10.4 Foreign Product Warranty.........................................14
10.5 Patent Infringement Warranty.....................................15
10.6 Limitation on Damages............................................15
ARTICLE XI - ARBITRATION...........................................................15
11.1 Arbitration......................................................15
11.2 Notification of Breach...........................................15
ARTICLE XII - MISCELLANEOUS........................................................15
12.1 Relationship of Parties..........................................15
12.2 Inspection of Facilities.........................................15
12.3 Entire Agreement.................................................15
12.4 Force Majeure....................................................15
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12.5 Severability.....................................................16
12.6 Assignment.......................................................16
12.7 Governing Law....................................................16
12.8 Notices..........................................................16
12.9 Counterparts.....................................................17
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EXHIBIT A - NOVEN'S PATENT RIGHTS
EXHIBIT B - TRANSDERMAL ESTROGEN SKIN PATCH PRODUCT SPECIFICATIONS
EXHIBIT C - SUPPLY AGREEMENT
EXHIBIT D - MENOREST BULK SPECIFICATIONS
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AMENDED AND RESTATED LICENSE AGREEMENT
THIS AMENDED AND RESTATED LICENSE AGREEMENT ("License Agreement")
originally made as of April 27, 1989 (the "Original Execution Date"), and
amended as of June 22, 1990, July 27, 1990, May 13, 1993, June 9, 1994, May 6,
1996, is amended and restated as of September 30, 1999 (the "Restatement Date")
and is by and between XXXXX-XXXXXXX XXXXX INC. (as successor to XXXXX GROUP
INC.), a Pennsylvania corporation having a place of business at 000 Xxxxxx Xxxx,
Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000 (hereinafter "RPR"), and NOVEN PHARMACEUTICALS,
INC., a Delaware corporation having a place of business at 00000 Xxxxxxxxx 000xx
Xxxxxx, Xxxxx, Xxxxxxx 00000 (hereinafter "Noven").
W I T N E S S E T H:
WHEREAS, as of the Original Execution Date the parties entered into
this License Agreement and a related supply agreement, pursuant to which they
agreed to collaborate on the development and marketing of a Transdermal Estrogen
Drug Delivery System (hereinafter defined as "Licensed Product"); and
WHEREAS, Noven represents and warrants that it has developed certain
information relating to, and is the owner of the entire right, title and
interest in and to, certain patents and patent applications having claims
covering the Licensed Product; and
WHEREAS, on several occasions since the Original Execution Date and
prior to the Restatement Date, the parties have amended this License Agreement
in various respects to reflect various amendments in their collaborative
venture; and
WHEREAS, the parties desire to amend and restate the License Agreement
to reflect the current status of the relationship between the parties.
NOW THEREFORE, it is mutually agreed between the parties hereto as
follows:
ARTICLE I - DEFINITIONS
1.1 AFFILIATES. The term "Affiliate" or "Affiliates" shall mean any
entity that is Controlled directly or indirectly by the party referred to, or
any entity that directly or indirectly Controls the party referred to, or any
entity that is directly or indirectly Controlled by an entity which also
directly or indirectly Controls the party referred to, so that the term shall
include any parent of the entity referred to or a directly or indirectly held
subsidiary of the parent or of the entity referred to, and entities in common
control with the entity referred to.
1.2 ***.
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1.3 CLINICAL AND PRODUCT DEVELOPMENT PROGRAM. The term "Clinical and
Product Development Program" shall mean a plan previously prepared by the
parties and performed under this License Agreement.
1.4 CONTROL. The term "Control," "Controls" or "Controlled" shall mean
the ownership, directly or indirectly, of at least fifty percent (50%) of the
voting rights attached to issued voting shares or the power to control decisions
made by any person or entity other than entities having shares. In addition if
any company or its Affiliate, which is one of the fifty largest in terms of
pharmaceutical sales, in the United States acquires sufficient shares of Noven
to exert de facto control, then such shall be considered control hereunder.
1.5 COSTS. The term "Costs" shall mean the fully allocated costs of the
party referred to including but not limited to the fully allocated cost of goods
and services and the manufacturing overhead related thereto. Cost shall be
determined by generally accepted accounting principles, applied on a consistent
basis, as determined by the independent certified public accountant retained by
the entity whose costs are being accounted for.
1.6 ESTROGEN TRANSDERMAL DRUG DELIVERY SYSTEM. The term "Estrogen
Transdermal Drug Delivery System" shall mean an estrogen in a multipolymer
comprising an acrylate and an ethylene/vinyl acetate polymer and a rubber,
adapted for transdermal delivery by application to the epidermis.
1.7 EUROPEAN ECONOMIC AREA. The term "European Economic Area" shall
mean the European Union and Iceland, Liechtenstein and Norway.
1.8 EXCLUDED COUNTRIES. The term "Excluded Countries" shall mean the
United States and Canada.
1.9 FINAL PROCESSING. The term "Final Processing" has the meaning set
forth in Article 6.2.
1.10 LICENSED PRODUCT. The term "Licensed Product" shall mean any
Estrogen Transdermal Drug Delivery System embodying any part of Noven's
Technology or covered in whole or in part by any of Noven's Patent Rights or
which meet the product specifications set forth in EXHIBIT B, said EXHIBIT B
being part of this License Agreement.
1.11 MACHINE. The term "Machine" has the meaning set forth in Article
6.4(a).
1.12 NET SALES. The term "Net Sales" shall mean the gross amount
invoiced by RPR, its Affiliates and Sublicensees on all sales of Licensed
Product less (a) discounts actually allowed, (b) credits actually allowed for
claims, allowances, retroactive price reductions or returned goods, (c) prepaid
freight, and (d) sales taxes, duties and other governmental charges actually
paid in connection with the sale, to the extent not reimbursed, (but excluding
what is commonly known as income taxes).
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1.13 NOVEN'S MACHINE PATENT RIGHTS. The term "Noven's Machine Patent
Rights" has the meaning set forth in Article 6.4(b).
1.14 NOVEN'S PATENT RIGHTS. The term "Noven's Patent Rights" shall mean
any and all patents and patent applications the claims of which cover the
Licensed Product including reissues, extensions and patents of addition, which
are owned by Noven or to which Noven has any right to control or to license
third parties (whether in whole or in part) at any time during the term of this
License Agreement. Patents on inventions made after December 31, 1994 are
included only to the extent based on inventions which were conceived or reduced
to practice by either party hereto during and under the Clinical and Product
Development Program. Noven's Patent Rights include, without limitation, the
United States patents and patent applications listed in Exhibit A attached
hereto and all corresponding foreign patents and patent applications.
1.15 NOVEN'S PROCESSING TECHNOLOGY. The term "Noven's Processing
Technology" has the meaning set forth in Article 6.4(b).
1.16 NOVEN'S TECHNOLOGY. The term "Noven's Technology" shall mean any
and all data, information, technology, know-how, process, technique, method,
skill, proprietary information, trade secret, development, discovery, and
inventions, owned or controlled by Noven and specifically related to an Estrogen
Transdermal Drug Delivery System existing as of Original Execution Date or
developed under and during the course of the Clinical and Product Development
Program. Noven's Technology shall not include information related to the
manufacture of Licensed Product and specifications and procedures related
thereto, except to the extent required for health registration of Licensed
Product and except to the extent of any license to manufacture granted under
this License Agreement.
1.17 PACKAGING MATERIALS. The term "Packaging Materials" shall mean the
cartons, labels, package inserts and patient package inserts that are used to
package the Licensed Product. The term does not include the pouches.
1.18 PACKAGING MATERIAL COSTS. The term "Packaging Material Costs"
shall mean ***.
1.19 STANDARD PACKAGING. The term "Standard Packaging" shall mean an
Estrogen Transdermal Drug Delivery System Licensed Product meeting the
specifications set forth in Exhibit B packaged in individual pouches and in
individual folding cartons consisting of eight (8) pouch units per carton and
containing any labels and labeling required by the applicable regulatory
authority.
1.20 SUBLICENSEE. The term "Sublicensee" and "Sublicensees" shall mean
any entity to whom RPR shall grant any right or license to use Noven's
Technology or to make, use or sell under all or any part of Noven's Patent
Rights or to make, use or sell any product which meets the specifications set
forth in EXHIBIT B.
1.21 TERRITORY. The term "Territory" shall mean all countries and
territories worldwide except Japan, Canada and the United States.
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ARTICLE II - OBLIGATIONS OF NOVEN
2.1 SUPPLY AND USE OF INFORMATION. Noven shall promptly provide to RPR,
for RPR's exclusive use, all Noven's Technology relating to Licensed Product,
subject only to the concurrent right of Noven and Noven's Affiliates to use the
same in the Excluded Countries. The parties shall, as promptly as possible,
provide to each other with any information that comes to the knowledge of a
responsible officer of any party relating to any adverse reaction occasioned
during research on or use of a Licensed Product. In countries where RPR needs
manufacturing information to obtain a product license, Noven shall supply the
necessary information solely for use in obtaining such license and subject to
the confidentiality obligations of Article VIII.
ARTICLE III - ONGOING DEVELOPMENT OBLIGATIONS
3.1 GOVERNMENTAL APPROVALS. RPR shall file requests with the
appropriate government agencies within the Territory for approval of Licensed
Product, except as to the Excluded Countries. The decision regarding the timing
of said filings within the Territory shall be in RPR's sole discretion. RPR
shall have full and complete ownership of all governmental approvals, except for
the Excluded Countries, relating to Licensed Product. Noven shall provide RPR
with full copies of and a right of reference to any application for
registrations and any registration in the Excluded Countries.
3.2 SUPPLY OF INFORMATION. RPR shall promptly and on a continuing basis
provide Noven, for use by Noven, with all information regarding RPR's technology
related to Licensed Product, on a royalty-free basis.
3.3 DILIGENCE. RPR shall use its commercially reasonable efforts to
file and obtain approval of appropriate governmental agencies for the sale of
Licensed Product, and to sell Licensed Product, in ***. RPR shall use such
commercially reasonable efforts to file and obtain approval of appropriate
governmental agencies, and sell Licensed Product, as it would for its own
products. ***.
3.4 COMPLETION OF CLINICAL AND PRODUCT DEVELOPMENT PROGRAM. The parties
agree that as of the Restatement Date each party has fully performed all its
obligations and paid for and/or reimbursed the other party with respect to the
Clinical and Product Development Program previously set forth in or provided for
pursuant to this License Agreement. The parties further agree that except as
expressly and specifically set forth herein, the provisions contained in this
License Agreement prior to the Restatement Date governed and shall continue to
govern any activities, obligations and/or disputes related to the Clinical and
Product Development Program, the development and approval of Licensed Product
thereunder and all intellectual property accruing therefrom. In addition, if the
parties elect to work together with respect to improvements to and/or the
development of second generation Licensed Product, they shall negotiate in good
faith a license or similar agreement to set forth the terms of such development
effort.
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ARTICLE IV - GRANT
4.1 LICENSE.
(a) Noven hereby grants to RPR, with the right to sublicense
RPR's Affiliates and Sublicensees subject to the provisions of Article 4.2
hereof, the exclusive right and license in the Territory to use, sell, or
otherwise dispose of Licensed Product under Noven's Patent Rights and Noven's
Technology.
(b) No right or license to make, use or sell under Noven's
Technology or Noven's Patent Rights is granted herein except as provided herein
and with reference to Licensed Product. No right of RPR, its Affiliates or
Sublicensees to manufacture Licensed Product is granted except to the extent
stated herein.
(c) The term "exclusive" used here means that Noven shall not
voluntarily grant a right to any third parties under Noven's Technology or
Noven's Patent Rights and RPR shall have the benefit of Article 5.8 hereof with
respect to such grant.
4.2 SUBLICENSE. As part of the rights granted in Article 4.1, RPR shall
have the right throughout the Territory to grant sublicenses to Sublicensees,
only with the prior written approval of Noven, which approval shall not be
unreasonably withheld. Such written approval by Noven shall not be required for
sublicenses to RPR Affiliates. Any such Sublicensee shall agree to assume the
duties of RPR hereunder with respect to the Territory involved, provided,
however, that such sublicense shall not release RPR from any liability for
performance under this License Agreement, except as set forth in the sublicense
agreement. Noven shall have no duty to approve any such sublicense until it
receives a copy of the proposed sublicense agreement, from which RPR shall have
the right to delete the financial terms.
ARTICLE V - PAYMENTS
5.1 INITIAL PAYMENTS. The parties agree that, as of the Restatement
Date, all initial payments, and related credits, required to be made or given,
as the case may be, under this License Agreement have been made or given.
5.2 FEE.
(a) RPR shall pay Noven with respect to each unit of Licensed
Product for which RPR performs the Final Processing a fee of *** of RPR's, its
Affiliates' and Sublicensees' Net Sales, subject to the provisions set forth in
this Article 5.2. RPR shall pay Noven with respect to each unit of Licensed
Product for which Noven performs the Final Processing a fee of *** of RPR's, its
Affiliates' and Sublicensees' Net Sales, plus all Packaging Material Costs used
in packaging the Licensed Product as set forth in Article 6.5 hereof, subject to
the provisions set forth in this Article 5.2. For any country with respect to
which RPR performs the Final Processing of any Licensed Product at any time
during a semi-annual period described in Article 5.4, RPR shall pay Noven the
fee of *** of RPR's, its Affiliates' and Sublicensees' Net Sales for all
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Licensed Product sold in such country during such semi-annual period. For any
country with respect to which Noven performs the Final Processing of all
Licensed Product during a semi-annual period described in Article 5.4, RPR shall
pay Noven the fee of *** of RPR's, its Affiliates' and Sublicensees' Net Sales
for all Licensed Product sold in such country during such semi-annual period,
with such fee calculated by: ***.
(b) Notwithstanding anything else to the contrary, the fee to
be paid under subparagraph 5.2(a) with respect to Licensed Product for which RPR
performs Final Processing shall be no less than *** per unit of Licensed
Product; provided, however, that for purposes of calculating such minimum fee,
RPR shall be deemed to obtain a fixed production yield of ***, regardless of the
yield RPR actually obtains. Such minimum fee shall therefore equate to a minimum
fee of *** per square yard of bulk material provided by Noven. The fee to be
paid under subparagraph 5.2(a) with respect to Licensed Product for which Noven
performs Final Processing shall be no less than *** per unit of Licensed
Product, plus all Packaging Material Costs as set forth in Article 6.5 hereof.
(c) Notwithstanding the foregoing, if Noven's Cost of Licensed
Product increases such that it is no longer commercially viable for Noven to
manufacture Licensed Product for the fee provided for in this Article 5.2, or if
RPR's weighted average gross margin for Licensed Product with respect to any
country, computed excluding samples and sales at or below cost, is reduced to a
point that it is no longer commercially viable for RPR to continue to market
Licensed Product in that country, then RPR and Noven shall negotiate in good
faith for a revised fee under this Article 5.2 with respect to Licensed Product.
In the absence of the parties being able to reach a mutually satisfactory
agreement, Noven shall grant RPR a non-exclusive license to manufacture Licensed
Product under Noven's Technology and Noven's Patent Rights in return for a ***,
in addition to other terms and conditions as reasonably agreed by the parties.
Such license shall only be for sales of Licensed Product in the country or
countries that occasioned the negotiation.
(d) The country-specific annual minimum fees payable by RPR to
Noven under Articles 5.3(a) and 5.3(b) shall be subject to reduction on a
country by country basis as follows: for any particular country with respect to
which RPR performs the Final Processing of any Licensed Product at any time
during a semi-annual period (as described in Article 5.4), one-half of the
minimum fee for that country for the year in which such semi-annual period falls
shall be reduced by 20%. (For the avoidance of doubt, this provision would
result in the reduction of the annual minimum fee for a given country in a given
year (i) by 10% if RPR performs Final Processing of any Licensed Product with
respect to such country at any time during only one semi-annual period in such
year and (ii) by 20% if RPR performs any such Final Processing at any time
during both semi-annual periods in such year. See the sample calculation in
Article 5.3(b).
(e) Notwithstanding any other provision of this License
Agreement, if RPR and Noven so agree, a sublicense agreement may provide that a
Sublicensee of RPR shall pay Noven directly the applicable fees set forth in
this Article 5.2 for Net Sales made by such Sublicensee. All calculation,
adjustment and payment term provisions of this License Agreement shall be
applicable to any such payments by a Sublicensee.
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5.3 MINIMUM FEE.
(a) RPR shall pay Noven a minimum fee per year beginning with
the first calendar year after product registration in the following countries as
follows:
MINIMUM FEE
PER CALENDAR YEAR FROM PRODUCT REGISTRATION
(YEAR 1 = YEAR OF PRODUCT REGISTRATION)
(U.S. $ in thousands)
COUNTRY YEAR 1 YEAR 1$ YEAR 2$ YEAR 3$ YEAR 4$ YEAR 5$
------- ------ ------- ------- ------- ------- -------
***
(b) For year 6 and subsequent years the minimum royalty shall
be the same as for Year 5 multiplied by a number, the numerator of which is the
total transdermal estrogen market in the country in question for which the
calculation is made and the denominator of which is the total transdermal
estrogen market in the country in question in Year 5. For the avoidance of
doubt, the parties agree that the applicable fee accrued in any given year is
due and paid in the following year once Licensed Product sales for such prior
year can be determined. (By way of example, the minimum fee with respect to ***
for 2000 (which is year 6 for that country) would be calculated as follows,
assuming that (i) RPR performed Final Processing for some Licensed Product for
*** during the first six-month period, but not during the second six-month
period and (ii) the total transdermal estrogen market in *** in 2000 was 5%
larger than it was in 1999:
Step 1: multiply the year 5 minimum fee by 105% -
$*** x 1.05 = $***
Step 2: subtract 20% of one-half of this number -
(i) one-half of $*** is $***
(ii) 20% of $*** is $***
(iii) $*** - $*** = $***
(The minimum fee would be $***)
(c) To the extent there is a difference in any country at the
end of each calendar year between any amount set forth in Article 5.3(a) and the
amounts set forth in Article 5.2(a), RPR shall pay the difference between the
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minimums and the amount actually paid within sixty (60) days of year end or this
License Agreement will become non-exclusive in that country. The parties
acknowledge that, as of the Restatement Date, the licenses granted hereunder are
exclusive in the Territory.
5.4 PAYMENTS. The fee due under Article 5.2(a) shall be payable as
follows: (a) the minimum fee under Article 5.2(b), plus an amount equal to ***
per unit for Packaging Material Costs, shall be due and payable within thirty
(30) days of Noven's invoice for the applicable Licensed Product, which invoice
shall be delivered simultaneously with the delivery of the Licensed Product; and
(b) within thirty (30) days after the end of each semi-annual calendar period
(i.e., January 1 to June 30 and July 1 to December 31), RPR shall make a payment
to Noven of the remaining fee, if any, due under Article 5.2(a) with respect to
such semi-annual period, based on Net Sales during the semi-annual period. The
parties agree that in any country where RPR performs any Final Processing in
such country during a semi-annual period, then no additional fee is due under
Article 5.2(a) with respect to sales in such period. The price for samples and
placebos provided for in Article 5.9 shall be payable in immediately available
funds within thirty (30) days of RPR's receipt of Noven's invoice for such
samples and placebos.
5.5 CURRENCY. Fees and royalties based on sales in a currency other
than United States dollars shall be converted to United States dollars at the
closing spot rate for the purchase of United States dollars on the last business
date of the calendar quarter for which payments are being accounted as published
by the Chase Manhattan Bank, New York.
5.6 RECORDS. RPR, its Affiliates and Sublicensees shall keep accurate
records in any way related to Licensed Product in accordance with generally
accepted accounting practices uniformly applied. At Noven's request, such
records shall be made available for examination by independent certified public
accountants or auditors designated by Noven and approved by RPR which approval
shall not be unreasonably withheld.
5.7 ONE ROYALTY. Only one royalty shall be paid on any Sale of Licensed
Product, namely the sale by RPR, its Affiliate or Sublicensee to an unrelated
third party.
5.8 COMPULSORY LICENSE. As an alternative, but not in addition to this
License Agreement, RPR shall have the benefit of the royalty provided for in any
compulsory license but to the exclusion of the benefits or rights under this
License Agreement for such country.
5.9 SAMPLES AND PLACEBOS. Noven shall supply pouched samples and
placebos of Licensed Product (clearly labeled as samples or placebos) as
requested by RPR at a price of *** per unit, ex works Noven's factory (Incoterms
1990) (as of July 1, 1999) plus *** per unit for Packaging Material Costs. On
July 1 of each year during the term of this License Agreement, the price set
forth in this Article 5.9 for samples and placebos shall be adjusted pursuant to
the Producer Price Index for finished goods published by the U.S. Department of
Labor, Bureau of Labor Statistics (hereafter referred to as the "Index"). The
price applicable after each such adjustment shall be determined by multiplying
the price set forth above by a fraction, the numerator of which shall be value
of the Index for the month and year in which the computation is made, and the
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denominator of which shall be the value of the Index on January 1, 1999. Should
the publication of the Index be discontinued by said U.S. Department of Labor
("DOL"), then such other indexes as may be published by the DOL most nearly
approaching the discontinued Index shall be used in determining the adjustment
hereunder. Should the DOL discontinue the publication of any such index, then
such index as may be published by another United States governmental agency, as
most nearly approximating the Index, shall govern and be substituted as the
Index hereunder.
ARTICLE VI - SUPPLY
6.1 AGREEMENT TO SUPPLY. Noven shall use its best efforts to supply and
RPR shall purchase all of RPR's, its Affiliates' and Sublicensees' requirements
of Licensed Product from Noven according to the terms and conditions set forth
in the Supply Agreement set forth in EXHIBIT C, which forms a part of this
License Agreement; however, should Noven be unable to meet RPR's requirements of
Licensed Product or by reason of force majeure is unable to import Licensed
Product into a country and if the parties, after having consulted in good faith
to resolve the matter, are unable to do so, RPR's sole remedy for Noven's
failure to supply shall be the right to a non-exclusive license to make or have
made Licensed Product under Noven's Technology and Noven's Patent Rights under
all other terms and conditions of this License Agreement in return for a ***.
6.2 FINAL PROCESSING OF LICENSED PRODUCT. Noven shall (a) manufacture
the Licenced Product through the stage of production of bulk rolls of active
pharmaceutical product, (b) test, prepare and package such bulk rolls, and (c)
supply and deliver them to RPR's facility in Nenagh, Ireland, or such other RPR
facility as RPR shall designate. Noven shall perform all such activities in
accordance with the terms of the Supply Agreement and this License Agreement,
the bulk laminate roll specifications attached hereto as EXHIBIT D and made a
part hereof (as may be amended by the parties from time to time), and all
applicable laws and regulations. RPR shall complete the processing of Licensed
Product in final form in accordance with the terms of the Supply Agreement and
this License Agreement. Specifically, RPR shall be responsible for die cutting
and scoring the bulk laminate rolls received from Noven and pouching, labeling,
cartoning, performing analytical testing of and releasing Licensed Product
(hereafter referred to as "Final Processing"). The price for Licensed Product
delivered by Noven to RPR under this Article 6.2 shall be as set forth in the
Supply Agreement and this License Agreement, and shall be ex works Noven's
factory. Title to and risk of loss to the bulk rolls shall pass to RPR ex works
Noven's factory, and RPR shall bear all costs and expenses for delivery of the
bulk rolls including, but not limited to, freight, insurance and duties.
6.3 BULK ROLLS.
(a) RPR shall cause its Affiliate in Ireland to purchase bulk
rolls of Licensed Product from Noven at a price equal to the minimum fee under
Article 5.2(b) hereof.
(b) Noven will invoice the RPR Affiliate in Ireland based on
the number of square yards of bulk rolls delivered by Noven to RPR pursuant to
Article 6.2.
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(c) In the event that Noven supplies bulk laminate rolls of
placebo material for educational or promotional purposes, such material shall be
supplied by Noven at an agreed upon price and no other fee or royalty shall be
due from RPR with respect to such material.
(d) Notwithstanding anything else to the contrary contained in
this License Agreement, Noven shall remain liable in accordance with the terms
and pricing of this License Agreement and the Supply Agreement to manufacture
and supply all Licensed Product processed in final form that RPR is unable, or
has inadequate capacity, or other conditions mutually agreed between RPR and
Noven, to process in final form pursuant to the terms of this License Agreement.
6.4 PROCESSING TECHNOLOGY AND EQUIPMENT.
(a) Noven grants RPR a non-exclusive license to use the die
cutting and pouch packaging machine (the "Machine") in RPR's Nenagh Ireland
facility under Noven's Processing Technology and Noven's Machine Patent Rights
(each as defined below), solely for RPR to perform Final Processing operations
under this License Agreement with respect to Licensed Product.
(b) The term "Noven's Processing Technology" shall mean any
and all data, information, technologies, know-how, processes, techniques,
methods, skills, proprietary information, trade secrets, developments and
discoveries, that are owned or controlled by Noven and specifically related to
the Machine and packaging operations with respect to Licensed Product, now
existing or developed in the future. The term "Noven's Machine Patent Rights"
shall mean any and all patents conceived or reduced to practice prior to
December 31, 1998, including but not limited to reissues, extensions and patents
of addition, and patent applications, continuations, divisionals and
continuations-in-part thereon that are owned or controlled by Noven and the
claims of which cover the Machine with respect to the Licenced Product. No right
or license to make, use or sell under Noven's Processing Technology or Noven's
Machine Patent Rights or right of resale, lease or transfer of any kind with
respect to the Machine is granted herein except as provided herein or with
reference to Licensed Product. No right to make or manufacture, or have made or
manufactured, Licensed Product is granted to RPR except to the extent stated
herein.
(c) Noven represents and warrants that it has no actual and
present knowledge of any rightful claim of any third party by way of
infringement or the like of any patent or other intellectual property rights
related to the Machine. Noven shall defend at its own cost and hold RPR harmless
from any such claims provided that RPR provides it prompt notice and an
opportunity to defend.
(d) Noven's Processing Technology and Noven's Machine Patent
Rights shall be subject to the confidentiality obligations of Article VIII. RPR
shall undertake all reasonable actions to restrict access to the Machine and
Noven's Processing Technology to its employees on a need to know basis and who
are bound to its obligations of confidentiality to the same extent as RPR is
bound to Noven.
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(e) In the event that RPR wishes to sell, lease or otherwise
transfer or dispose of the Machine, Noven shall have an exclusive right of first
refusal on such terms as may be mutually agreed upon by the parties acting in
good faith. If Noven does not agree to such terms within forty-five (45) days of
receipt of a written offer from RPR, then RPR may sell, lease or otherwise
transfer or dispose of the Machine to a third party on terms no less favorable
to RPR than those proposed to Noven.
(f) RPR shall not move the Machine from its manufacturing
facility in Nenagh, Ireland, to another facility without having first given
written notice to Noven.
(g) RPR shall not copy, duplicate or otherwise reproduce the
Machine or components thereof.
6.5 PACKAGING.
(a) In the case in which Noven engages in Final Processing of
the Licensed Product, Noven shall supply and deliver Licensed Product in
finished, packaged form to such facilities as RPR shall designate. Noven shall
perform manufacturing and packaging activities in accordance with the terms of
this License Agreement, as amended, including the approved specifications and
all applicable laws and regulations. The price for Licensed Product supplied in
finished, packaged form shall be as set forth in Article 5.2, and shall be ex
works Noven's factory. Title to and risk of loss to the Licensed Product shall
pass to RPR ex works Noven's factory, and RPR shall bear all costs and expenses
for delivery of the Licensed Product including, but not limited to, freight,
insurance and duties.
(b) As set forth in Article 5.4, the fee per unit paid by RPR
pursuant to Article 5.2 and the price per unit paid by RPR pursuant to Article
5.9 each includes *** for Packaging Material Costs used by Noven in packaging
Licensed Product for supply to RPR. Commencing July 1, 1999, and each six months
thereafter, Noven shall calculate its actual per unit Packaging Material Costs
for the six-month period then ended. To the extent that Noven's actual per unit
Packaging Material Costs exceeded *** for such period, Noven shall invoice RPR
for such difference and RPR shall pay such amount in immediately available funds
within thirty (30) days of RPR's receipt of Noven's invoice. The parties agree
that RPR shall reimburse Noven for the cost of all Packaging Material Costs
purchased by Noven for use in packaging Licensed Product for supply to RPR,
regardless of whether such Packaging Materials are actually used in packaging
Licensed Product; provided that RPR shall not be responsible for reimbursing
Noven for any Packaging Material Costs for Packaging Materials purchased by
Noven in excess of the quantities required to meet RPR's forecast delivered
pursuant to the Supply Agreement for the six months following the date of
purchase by Noven. Without limiting the foregoing, RPR shall reimburse Noven for
any Packaging Material Costs for Packaging Materials rendered unusable because
of a change in RPR's labeling or packaging specifications or requirements.
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ARTICLE VII - PATENTS
7.1 NOVEN INVENTIONS. On all inventions conceived or made under and
during the scope of the Clinical and Product Development Program for which Noven
(through its employees and consultants) is the sole inventor, Noven shall
obtain, at its own expense, and own any patents in the countries requested by
RPR and these inventions shall become a part of Noven's Patent Rights. RPR shall
decide unilaterally in which countries RPR wishes patent protection and Noven
shall, at Noven's expense, file patent applications in such countries in the
name of Noven, and Noven shall have all right, title and interest therein,
subject to the other provisions of this License Agreement. RPR shall have the
duty to pay all costs and fees for such filings in any and all said countries in
the Territory for so long as RPR is not selling Licensed Product in such country
or is not paying the minimum royalties with respect to such countries.
7.2 JOINT INVENTIONS. On all inventions conceived or made under and
during the scope of the Clinical and Product Development Program which are joint
inventions of an employee(s) or consultant(s) of Noven and an employee(s) or
consultant(s) of RPR, or an Affiliate of RPR, the parties to this License
Agreement shall have joint ownership of any patent applications and patents
obtained thereon, and RPR shall pay all costs and expenses of obtaining and
maintaining such patent rights within the Territory, provided, however, that
one-half (1/2) of all such expenses in a country payable by RPR shall be a
credit against one-half (1/2) of any royalties otherwise due Noven in such
country. RPR shall have the sole right to decide in which countries RPR wishes
patent protection on an invention developed hereunder. RPR shall keep Noven
fully and promptly informed with respect to the countries in which RPR elects to
obtain patent protection, and Noven may, at its own expense, apply for and
obtain patent protection in any country in which RPR does not elect to obtain
such patent protection.
7.3 RECIPROCAL RIGHTS TO EXPLOIT DATA. RPR shall have the unrestricted
right to use any data derived from any existing or future study on Licensed
Product, whether conducted by RPR, Noven or a third party, in any country or
area of the Territory. Noven shall similarly have the unrestricted right to use
any such data, but only in the United States, Canada and Japan.
ARTICLE VIII - CONFIDENTIALITY OBLIGATIONS
8.1 CONFIDENTIALITY. Except to the extent that any of the data,
information or know-how developed by either party, including but not limited to
Noven's Technology, is in the public domain at the time of disclosure or
subsequently enters the public domain without fault on the part of a party
hereto, each party shall hold all such data, information, or know-how received
from the other prior to or during the term of this License Agreement in
confidence and shall not disclose it to any other entities during the term of
this License Agreement or thereafter without the other party's permission in
writing. Such permission shall not be withheld (a) to the extent disclosure is
required by legal process to which process the generating party is permitted to
object; or (b) to information required to be submitted to governmental
authorities in order to obtain any necessary health registration or price
reimbursement. Such permission shall not be unreasonably withheld as to other
information reasonably required for obtaining health registration or insurance
reimbursement approval or in marketing Licensed Product. Notwithstanding the
foregoing, RPR shall have the right to use and disclose after the year 2010
Noven's Technology existing on the Original Execution Date or twenty (20) years
after its disclosure as to data generated after the Original Execution Date, if
this License Agreement expires by its normal terms, as set forth in Article 9.1
hereof.
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Securities and Exchange Commission. Asterisks denote omissions.
ARTICLE IX - TERM AND TERMINATION
9.1 TERM.
(a) This License Agreement shall take effect as of the
Original Execution Date and continue in full force and effect in each country
throughout the Territory until the date of expiration of the last to expire of
Noven's Patent Rights in such country.
(b) In countries where Noven has no Patent Rights, the term of
this License Agreement shall be for fifteen (15) years from the date of first
commercial sale in such country. Termination of this License Agreement shall
take place on a country-by-country basis.
(c) Upon expiration of this License Agreement pursuant to
this Article 9.1 in any country, RPR shall have the right to elect to renew this
License Agreement for successive five-year terms by giving Noven written notice
of its intention to do so prior to the end of any such term; provided, however,
that in the event of any such renewal the parties will negotiate in good faith
the fees provided for in Article 5.2 to take account of the expiration of the
applicable patents.
(d) Notwithstanding any other provision of this License
Agreement, for those countries within the European Economic Area, any pure
know-how license granted hereunder under Noven's Technology will remain
exclusive only for a period of ten (10) years following the first sale of
Licensed Product in any country within the European Economic Area, and following
the expiration of such ten-year period, the license to the applicable know-how
under the Noven Technology shall automatically convert to a non-exclusive
license to use, sell or otherwise dispose of Licensed Product in the European
Economic Area for the remainder of the term; provided, however, that in such
event the parties will negotiate in good faith the fees provided for in Article
5.2 to take account of the non-exclusive nature of the license in the European
Economic Area.
9.2 TERMINATION.
(a) If either RPR or Noven should fail to discharge fully and
promptly any of its obligations under this License Agreement, including but not
limited to the Supply Agreement, attached as EXHIBIT C, including the obligation
to make payments, and should such party failing to discharge any of its
obligations fail to rectify such failure within ten (10) days in the case of
failure to make payments or within sixty (60) days for other failures after
notice in writing thereof by the other party, this License Agreement can
thereupon be terminated at the other party's option upon receipt of notice to
that effect.
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Securities and Exchange Commission. Asterisks denote omissions.
(b) Any one party hereto shall have the right to terminate
this License Agreement with immediate effect in the event of any proceeding
under a Bankruptcy Act or any insolvency, receivership or dissolution proceeding
directed against the other party.
(c) Noven shall have the right to terminate this License
Agreement at any time upon thirty (30) days' notice in the event that RPR or any
RPR Affiliate or Sublicensee or any entity to whom RPR sells its ethical
pharmaceutical business markets, sells or distributes any Estrogen Transdermal
Drug Delivery System other than Licensed Product; provided, however, that this
right of termination does not apply (i) with respect to the countries in the
European Economic Area, (ii) ***. During the term of this Agreement, if RPR or
any RPR Affiliate or Sublicensee or any entity to whom RPR sells its ethical
pharmaceutical business markets, sells or distributes any Estrogen Transdermal
Drug Delivery System other than Licensed Product in a country within the
European Economic Area, then Noven, with regard to such country, shall have the
right to convert the license granted under Article 4 to a non-exclusive license;
provided, however, that this right shall not apply ***.
(d) Upon termination, all information and data, relating to
Licensed Product including but not limited to Noven's Technology, and
information obtained from, incorporating or based on Noven's Technology shall be
returned to Noven. RPR, its Affiliates and Sublicensees shall make no further
use of the same. The foregoing shall not apply to information solely generated
by RPR, if termination is by RPR for cause of Noven or by expiration of the term
specified in Article 9.1.
ARTICLE X - NOVEN WARRANTIES
10.1 OWNERSHIP. Noven represents and warrants that it has developed
Noven's Technology and it owns the entire right, title and interest in the
patent and patent applications now set forth in EXHIBIT A.
10.2 RIGHT TO ENTER AGREEMENT. Noven warrants that it has the right to
enter into this License Agreement, and that there are no outstanding
assignments, grants, licenses, encumbrances, obligations or agreements, either
written, oral or implied, inconsistent with this License Agreement.
10.3 PRODUCT WARRANTY. Noven represents and warrants that Licensed
Product in the form delivered to RPR shall conform to specifications for any
such product, including composition, purity, appearance and stability and shall
be capable of maintaining such until any expiration date for such Licensed
Product; and shall not be misbranded in violation of Sections 501, 502 and 505
of the Federal Food, Drug and Cosmetic Act, as amended from time to time.
10.4 FOREIGN PRODUCT WARRANTY. Noven will use its best efforts to
comply with manufacturing specifications of foreign countries of which RPR has
given Noven specific notice, provided that RPR pays all Cost of such compliance.
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Securities and Exchange Commission. Asterisks denote omissions.
10.5 PATENT INFRINGEMENT WARRANTY. Noven represents and warrants that
it has no present knowledge of any patent, the claims of which cover Licensed
Product.
10.6 LIMITATION ON DAMAGES. In the event of any breach of any
representation and warranty of Noven under this Article X damages shall be
limited to actual damages and shall not exceed the royalty payable to Noven
hereunder in any calendar year or in the case of the warranty against patent
infringement, shall not exceed fifty (50%) percent of the royalties paid to
Noven in any such calendar year for the country in question.
ARTICLE XI - ARBITRATION
11.1 ARBITRATION. Any claim or controversy arising between the parties
hereto in connection with this License Agreement or the breach hereof which
cannot be settled satisfactorily by correspondence or by mutual conference shall
be determined by arbitration in New York, New York, by three arbitrators in
accordance with the then prevailing rules of the American Arbitration
Association upon the request by either party. Judgment upon the award rendered
may be entered in any court having jurisdiction thereof.
11.2 NOTIFICATION OF BREACH. In the event one party notifies the other
party of a breach of this License Agreement, and such breach is not cured within
the applicable notice period, such other party shall have the right within said
sixty (60) day period to bring such dispute to arbitration.
ARTICLE XII - MISCELLANEOUS
12.1 RELATIONSHIP OF PARTIES. The parties hereto have the relationship
of independent contractors, and neither party shall enter into any agreements,
understandings or commitments on behalf of the other party without the other
party's express permission in writing.
12.2 INSPECTION OF FACILITIES. At any time during the term of this
License Agreement and any extension thereof, RPR may from time to time during
normal working hours have employees of its choosing visit and inspect the
facilities of Noven, and may discuss with Noven employees the progress of
projects under development by Noven.
12.3 ENTIRE AGREEMENT. This License Agreement represents the entire
understanding between the parties and supersedes any and all previous
understandings, both oral and written, with respect to the subject matter
hereof. The terms, conditions and provisions of this License Agreement shall
prevail over any inconsistent statements, terms, conditions or provisions
contained in any document passing between the parties hereto including, but not
limited to, any acknowledgment, confirmation or notice. This License Agreement
may not be amended, supplemented, or otherwise modified except by an instrument
in writing designated as an amendment, supplement or modification which is
signed by both parties hereto.
12.4 FORCE MAJEURE. If the performance of this License Agreement or any
obligation reasonably related thereto is prevented or hindered, by reason of any
cause beyond the control of the affected party, including but not limited to,
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Securities and Exchange Commission. Asterisks denote omissions.
fire, flood, riot, strikes or any governmental action, then the party so
affected, upon notice to the other party, shall be excused from such
performance, provided that the party so affected shall use its best efforts to
avoid or remove such cause or causes of non-performance and shall continue to
perform thereunder with the utmost dispatch whenever such cause or causes are
removed. If, as a result of any such action, the performance of this License
Agreement is prevented for a continuous period of one hundred eighty (180) days,
either party shall have the right to terminate this License Agreement as to the
country or countries involved by providing the other party with written notice
of termination.
12.5 SEVERABILITY. If any provision of this License Agreement shall be
held invalid or unenforceable, such invalidity or unenforceability shall attach
only to such provision and shall not in any manner affect or render invalid or
unenforceable any other severable provision of this License Agreement, and this
License Agreement shall be carried out as if any such invalid or unenforceable
provision were not contained herein.
12.6 ASSIGNMENT. This License Agreement shall inure to the benefit of
the parties and to the successors and assigns of that part of the business of
RPR to which the subject matter of this License Agreement is related. This
License Agreement, or any rights hereunder, shall not otherwise be sold,
assigned, transferred or encumbered by either party without first obtaining the
consent of the other party in writing; provided, that RPR may assign or transfer
any of its rights and obligations to any of its Affiliates and to any successors
or assigns of that part of its business to which the subject matter of this
License Agreement is related.
12.7 GOVERNING LAW. This License Agreement shall be interpreted in
accordance with and governed by the laws of the State of New York, without
references to the conflict of law rules. Both parties forever waive any defense
or claim that New York law cannot be validly applied to this License Agreement.
12.8 NOTICES. Any notice or report required or permitted hereunder
shall be given in writing, hand delivered or by registered or certified mail, to
the following addresses:
(1) Noven Pharmaceuticals, Inc.
00000 Xxxxxxxxx 000xx Xxxxxx
Xxxxx, Xxxxxxx 00000
Attention: President
With a copy to: Noven Pharmaceuticals, Inc.
00000 Xxxxxxxxx 000xx Xxxxxx
Xxxxx, Xxxxxxx 00000
Attention: General Counsel
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Securities and Exchange Commission. Asterisks denote omissions.
(2) Xxxxx-Xxxxxxx Xxxxx Inc.
000 Xxxxxx Xxxx
Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000
Attention: President
With a copy to: General Counsel
Xxxxx-Xxxxxxx Xxxxx Inc.
000 Xxxxxx Xxxx
Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000
or to such other address or in care of such other person as hereafter shall be
designated in writing by either party to the other, and shall be deemed to have
been given as of the date of mailing.
12.9 COUNTERPARTS. This License Agreement and any amendments may be
executed in one or more counterparts, each of which shall be deemed an original
but all of which together will constitute one and the same instrument.
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IN WITNESS WHEREOF, the parties hereto have caused this Amended and
Restated License Agreement to be executed in duplicate and their seals to be
hereunto affixed as of the day and year first written above.
XXXXX-XXXXXXX XXXXX INC. (as successor
to XXXXX GROUP INC.)
By: /s/ Xxxxxx xx Xxxxx
----------------------------------------
Xxxxxx xx Xxxxx
Chairman and Chief Executive Officer
NOVEN PHARMACEUTICALS, INC.
By: /s/ Xxxxxx X. Xxxxxxx
----------------------------------------
Xxxxxx X. Xxxxxxx
President and Chief Executive Officer
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EXHIBIT A
NOVEN'S PATENT RIGHTS
***
A-1
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
EXHIBIT B
TRANSDERMAL ESTROGEN SKIN PATCH PRODUCT SPECIFICATIONS
***
B-1
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
EXHIBIT C
SUPPLY AGREEMENT
C-1
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
EXHIBIT D
MENOREST BULK SPECIFICATIONS
***
D-1
